ROCKVILLE, Md. - The Food and Drug Administration (FDA) recently approved the first Lyme disease vaccine (LYMErix, SmithKline Beecham Biologicals) for the prevention of Lyme disease.
LYMErix has been proven effective in the prevention of both definite Lyme disease (characteristic symptoms with serologic diagnosis) and asymptomatic infection (no symptoms, but serologic diagnosis of infection).
LYMErix is a genetically engineered vaccine that contains lipoprotein OspA, an outer surface protein of Borrelia burgdorferi. A novel hypothesis has been proposed to explain the efficacy of lipoprotein OspA vaccination: when infected ticks bite humans who have been vaccinated with LYMErix, the vaccine-induced antibodies are taken up by the tick and interact with the B. burgdorferi in the midgut of the tick, thereby preventing transmission of the organism to the host.
Lyme disease is a potentially serious multistage bacterial infection with a wide range of symptoms; from a characteristic skin rash and influenza-like symptoms to arthritis and heart abnormalities. According to the Centers for Disease Control and Prevention (CDC), Lyme disease has become the most common tickborne illness, with cases reported in 48 states. More than 99,000 cases were reported between 1982 and 1996, and people at highest risk include those living in, working in or traveling to endemic areas in the United States, including the Northeast, upper Midwest and Pacific coastal areas, the CDC stated.
A recent study published in Clinical Therapeutics indicates the economic burden of Lyme disease in the United States is projected to be $2.5 billion in direct and indirect medical costs over a five-year period.
"The approval of LYMErix is especially significant for people who live in or travel to B. burgdorferi infected, tick-infested areas, or people who enjoy outdoor activities in these areas," said Vijay Sikand, MD, clinical trial investigator and adjunct assistant professor of medicine, Tufts University School of Medicine, Medford, Mass. "Now that a vaccine will be available, at-risk individuals should start getting vaccinated against Lyme disease in order to begin building immunity for the upcoming Lyme disease season."
LYMErix was evaluated in a landmark clinical trial that enrolled 10,936 individuals ranging from 15 to 70 years of age at 31 U.S. sites in endemic areas. Results from the multicenter, double-blind, placebo-controlled clinical trial demonstrated vaccine efficacy rates of 78% against definite Lyme disease and 100% against asymptomatic infection after three doses (after two doses, vaccine efficacy rates were 50% and 83%, respectively). Study participants received three doses of LYMErix or placebo on a 0, 1 and 12-month schedule. Compliance in the study was high with 95% of participants completing the 20-month study.
"This action by the FDA is an important milestone in the prevention of Lyme disease," said Eddie Gray,vice president and director, SmithKline Beecham's U.S. Vaccine Business Unit. "The approval of LYMErix means the threat of Lyme disease may be significantly reduced for millions of Americans who spend time outdoors or plan to travel to endemic areas."
LYMErix may be associated with local injection-site reactions including redness and swelling, influenza-like symptoms, arthralgias and myalgias.
For more information on Lyme disease and LYMErix, call toll-free 1-888-LYMERIX, ext. 500.
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